510(k) K222657
K222657 is an FDA 510(k) premarket notification submitted by Mebo Life Science, Inc. for the device "MEBO Wound Dressing". The FDA issued a decision of Substantially Equivalent on Oct 18, 2022. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Mebo Life Science, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 18, 2022
- Date Received
- Sep 2, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)